US EPA publishes significant three-year action plan: the Strategic Roadmap for PFAS 2021

Authored by Victoria Smart

On October 18, 2021, the U.S. EPA announced PFAS Strategic Roadmap to address contamination from PFAS (Perfluoroalkyl and Polyfluoroalkyl Substances, which is a class of substances). EPA has set 2023 as the target deadline for a final rule regulating PFOS and PFOA (within the class of PFAS) in drinking water, and for designation of the two compounds as hazardous substances.

The EPA’s roadmap includes pledges for research and testing on hundreds of chemicals/compounds within the set of PFAS, and could classify as hazardous substances other PFAS compounds. EPA may move toward regulation of PFAS as a class, or toward regulation of sub-groups with similar properties or impacts, or both. The American Chemical Council issued a statement that “all PFAS are not the same, and they should not all be regulated the same way. EPA’s Roadmap reinforces the differences between these chemistries…they should not all be grouped together”

The EPA’s three-year action plan sets targets for significant achievements in the control of PFAS in products, water, air and soil, including:

  • Publish national PFAS testing strategy  –  Fall 2021
  • Finalize new PFAS reporting under TSCA Section 8 –  Winter 2022
  • Establish a robust review process for new PFAS
  • Review previous decisions on PFAS
  • Enhance PFAS reporting under the Toxics Release Inventory – Spring 2022
  • Finalize new PFAS reporting under TSCA Section 8
  • Undertake nationwide monitoring for PFAS in drinking water Final Rule – Fall 2021
  • A National primary drinking water regulation for PFOA and PFOS Proposed Rule – Fall 2022, Final Rule Expected Fall 2023
  • Publish toxicity assessments for GenX (hexafluoropropylene oxide dimer acid and its ammonium salt,) and five additional PFAS – (PFBA, PFHxA, PFHxS, PFNA, and PFDA) –  Fall 2021 and Ongoing; with Health Studies to be released in 2022.
  • Restrict PFAS discharges from industrial sources through a multi-faceted Effluent Limitations Guidelines program – Expected 2022
  • Leverage NPDES permitting to reduce PFAS discharges to waterways  –  Winter 2022
  • Propose to designate certain PFAS as CERCLA hazardous substances  – Proposed rule Spring 2022; Final rule Summer 2023
  • Issue updated guidance on destruction and disposal of certain PFAS and PFAS-containing materials – by Fall 2023
  • Build technical foundation to address PFAS air emissions  –  Fall 2022
  • Develop and validate methods to detect and measure PFAS in the environment

The EPA’s PFAS program is outlined here.

EU REACH – Public access to ECHA’s chemicals database on SVHCs: improved consumer and supply chain awareness or heightened legal risks?

Authored by Sarah-Jane Dobson of Cooley LLP

Recently, the European Chemicals Agency (ECHA’s) database of Substances of Very High Concern (“SVHCs”) has been opened to allow the public to access it. The database lists details of articles containing SVHCs across a broad range of product categories, from food footwear to foodstuffs.

This development brings with it both opportunities, but also risks. The change is likely to significantly impact consumer behavior. Being more able to scrutinize their chemical composition, consumers are likely to be more selective about which products they chose to purchase. With the additional granular information provided to them at their fingertips, consumers or consumer interest groups may also be better equipped to take action, whether informal or formal (including legal action), against companies. For manufacturers and those in the supply chain, this increased accessibility to detailed information about products arguably gives greater control to manage any downstream risk, which is likely beneficial in respect of chemical laws, but also in respect of increasingly onerous corporate social responsibility requirements that rely on detailed information about component aspects of products and their supply chain and which apply to many product categories that are listed on the database.

SVHCs are substances which contain more than 0.1% weight by weight of chemicals listed on the REACH Candidate List, a list of potentially hazardous substances that are regulated by REACH. Since 5 January 2021, manufacturers and importers that supply articles containing these SVHCs, have been required to notify these to ECHA Companies. These obligations are contained within the EU Waste Framework Directive (“WFD”), which sets out basic concepts and definitions relating to waste management, including specifically addressing the historic regulatory gap which used to exist regarding the disposal of REACH- regulated products. All SVHC notifications are stored in the ECHA’s “Substances of Concern in Products (SCIP) database”, set out under the WFD. There is a particularly broad range of articles listed in the database across a wide range of product categories.

The SCIP database has now reached an important milestone in its development. From 14 September 2021, public access to the database was granted and consumers have been able to search the data by article name or brand, product category, type of material or the chemical name.

The public now have access to all information contained on the database, which includes comprehensive records on chemicals issues throughout the whole lifecycle of products and materials, including the waste stage. Examples of specific, particularly relevant pieces of information that consumers and the general public can obtain from the database include technical data to identify the article, instructions on how to use it safely, the SVHC, its location, and the type of material in which it is contained.

A snapshot of the overall trends that the database has allowed insight into include:

Most commonly notified product categories in the database Most commonly SVHCs in notifications
  • Machinery and their parts
  • Measuring instruments and their parts
  • Electronic equipment and their parts
  • Vehicles and their parts
  • Articles made of rubber
  • Furniture
  • Lead (e.g. in ball bearings, batteries)
  • Lead monoxide (e.g. in lamps, vehicle parts)
  • Lead titanium trioxide (e.g. in electric cookers)
  • Silicid acid, lead salt (e.g. in lead crystalware, vehicle coatings)
  • Dechlorane PlusTM (e.g. in paints, glues)

Practical impact

There are numerous practical impacts of the database being publicly accessible now, some of which are policy drivers behind the move:

  • Ordinary consumers and/or consumer interest groups may make more informed choices by checking whether a product contains hazardous chemicals and reading its safe use instructions.
  • Waste operators may utilise the data to increase the re-use of articles and further develop recycling processes and safe instructions for disposal.
  • Increased transparency in the use of SVHCs may act as a driver for substitution i.e. to get extremely hazardous substances out of products wherever possible. This aligns with the EU’s growing focus on substituting hazardous chemicals in products wherever possible. Non-Governmental Organisations, or NGOs, therefore have a vested interest in using the data to advance goals relating to substitution, sustainability and safer chemicals.
  • It is expected that the database will act as an enabler to the EU’s circular economy action plan to put further emphasis on the tracking of SVHCs and support the policy drivers for cleaner waste streams and sustainable consumption.

Overall, this development is an important milestone in global product safety policy. If there are better informed consumers in relation to both ingredients or restrictions on certain substances, there is a growing risk for companies that more consumer claims may be brought in respect of particular products or articles. Consumers or consumer interest groups may also exercise additional rights in respect of requests for more detailed information and/or simply be better informed to ask companies more detailed questions on these topics. Producers should be alive to this growing potential risk when considering the use of SVHCs.

The development provides a rare opportunity for companies also – given the supply chain for modern-day products is complex, this database can assist producers of articles in gaining much better visibility on the ingredients they use when manufacturing. By identifying these substances upfront, safer alternatives may be sought out or pressure on downstream suppliers may be applied to better align their practices with the forward- looking policy of the EU’s chemicals and waste regime regarding safety and environmental and social concerns.

US EPA extends reporting deadline for Health and Safety Data on 20 high-priority chemicals and 30 organohalogens

The US EPA, on September 23, issued a prepublication version of a rule that would extend the reporting and submission deadline for the Health and Safety Data Reporting rule under TSCA. The deadline is extended to December 1, 2021 for High Priority Substances (twenty), and to January 25, 2022 for the thirty (30) organohalogen flame retardants.

The Health and Safety Data Reporting Rule, promulgated under TSCA section 8(d), requires manufacturers (including importers) of certain chemical substances to submit lists and copies of certain unpublished health and safety studies to the EPA.  In its draft notice and rule, EPA notes it has not issued TSCA Section 8(d) rules for several years; and because of the time lapse, manufacturers may not be familiar with certain compliance requirements.  EPA has posted an “historic” 1989 guide for this purpose.  The 22-page guide,

General Questions and Answers About Reporting Under the TSCA s 8(d) Health and Safety Study Reporting Rule  clarifies what type of monitoring reports must be submitted, how the definition of “study” as applied to monitoring data relates to operations reports, and that the rule exempts the submission of underlying data.

The Rule, in pre-publication, is posted here. This final rule will be effective as of the date of publication in the Federal Register.

EU SCIP – Know More About Hazardous Chemicals in Products

You can now access data from the EU’s first public database of substances of very high concern in products, SCIP. It aims to allow consumers to make more informed purchasing choices and help waste operators to further develop the re-use of articles and the recycling of materials.

Helsinki, 14 September 2021 – Around 6 000 companies across the European Union have successfully complied with their new duty to notify ECHA about products containing substances of very high concern, SVHCs. The SCIP database now displays more than four million article notifications.

Based on the information submitted so far, the most commonly notified product categories in the database are:

  • machinery and their parts;
  • measuring instruments and their parts;
  • electronic equipment and their parts;
  • vehicles and their parts;
  • articles made of rubber; and
  • furniture.

The most common substances of very high concern in notifications are:

  • lead (e.g. in ball bearings, batteries);
  • lead monoxide (e.g. in lamps, vehicle parts);
  • lead titanium trioxide (e.g. in electric cookers);
  • silicid acid, lead salt (e.g. in lead crystalware, vehicle coatings); and
  • 1,6,7,8,9,14,15,16,17,17,18,18 Dodecachloropentacyclo [12.2.1.16,9.02,13.05,10]octadeca-7,15- diene, more commonly referred to as “Dechlorane PlusTM” (e.g. in paints, glues)

You can search the data by article name or brand, product category, type of material or the chemical name. The data will help consumers make informed choices by checking whether a product contains hazardous chemicals and reading its safe use instructions. Waste operators can use the data to increase the re-use of articles and further develop recycling processes.

ECHA’s Executive Director, Bjorn Hansen says: “Today’s launch improves access to information on hazardous chemicals in articles on the EU market. It will help to track products containing substances of very high concern until they reach the waste stage, supporting the goals of a circular economy. We encourage everyone to get familiar with the database and use it.

Virginijus Sinkevičius, EU Commissioner for Environment, Oceans and Fisheries, says: “The launch of the database is a true milestone in bringing transparency about chemicals of concern in products. This wealth of information will be of great value to all, especially consumers, waste operators, and policy-makers. It will enhance the delivery of safe and clean products and secondary materials, fully in line with the priorities on re-use and recycling defined in the EU waste legislation. Thanks to all the companies that promptly submitted information, making the database work. This is a key step in implementing deliverables of the European Green Deal, notably our action plans on circular economy and zero pollution, and our Chemicals Strategy for Sustainability.

All companies placing articles containing substances of very high concern on the EU market have to notify them to the database. To help companies with this duty, ECHA has developed several guidance documents and tools.

Background

Companies supplying articles that contain substances of very high concern, SVHCs, on the REACH Candidate List have to notify these to ECHA. The requirement concerns articles on the EU market that contain more than 0.1 % weight by weight of SVHCs. The obligation came into force on 5 January 2021 and is based on the EU Waste Framework Directive as revised in 2018.
The notifications are stored in the Substances of Concern in Products (SCIP) database, which ensures that the information is publicly available throughout the whole lifecycle of products and materials, including the waste stage.

SCIP provides all the technical data from companies allowing the safe use and improved re-use and recycling of the article. This includes: information to identify the article, instructions on how to use it safely, the substance of very high concern, its location, and the type of material in which it is contained.

At the moment, the database contains over four million article notifications. This number counts duplicate notifications for the same article that were made by several actors in the EU supply chains, as well as notifications made for more than one article. Therefore, ECHA does not have an estimation for the exact number of different articles in the database.

PFAS Updates in the U.S. and EU

U.S. PFAS Update: EPA Public Comment Period Open Now

In June, the U.S. Environmental Protection Agency (EPA) issued a “Pre-publication Notice for TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances.”

The notice was ultimately published in the Federal Register on June 27. The EPA will accept public comments on the proposed rule until September 27.

A few key points for manufacturers to understand are:

  1. This one-time regulation will authorize EPA to request and obtain information about products containing over 1,100 different PFAS substances imported into the country or manufactured in the USA over the past ten years
  2. This regulation was mandated in the National Defense Authorization Act for Fiscal Year 2020. See Sec. 7351, “PFAS DATA CALL”
  3. The EPA has required this level of information in the past from industry, but, as far as I can tell, never from article-manufacturing industries. The key sentence resulting in the inclusion of these industries is:

… articles containing PFAS, including imported articles containing PFAS (such as articles containing PFAS as part of surface coatings), are included in the scope of reportable chemical substances.

In my opinion, the EPA significantly underestimates the number of respondents at 234 and the total estimated cost at just under $10 million per year for the entirety of the American manufacturing industry. A better understanding of the electronics industry and the supply chain would undoubtedly result in a far greater number of respondents and far higher cost estimate.

Note that small businesses are not excluded from these rules.

The EPA must publish a final rule no later than January 1, 2023. A six-month reporting period would begin six months after the effective date of the final rule. Now is the time to get your comments in!

European Union PFAS Update

On July 21, the European Chemicals Agency issued an email that said:

DenmarkGermanythe NetherlandsNorway and Sweden have submitted an intention to restrict the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS) (EC/CAS -) on 15 July 2021. We expect to receive their restriction proposal by 15 July 2022.

The five countries have launched a survey on PFAS and their alternatives and are looking for more information for the intended restriction. The deadline for comments is 19 September 2021.

A regulatory management option analysis conclusion document (RMOA) is also available on our website.

As the amount of focus and level of interest has risen on PFAS in general over the past decade (beyond PFOA and PFOS), the likelihood of action has risen as well. Manufacturers whose products are dependent on these substances at any level would do well to assess their essentiality and alternatives as quickly and thoroughly as possible.

USA TSCA Chemical Inventory Biannual Update Posted

The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the U.S. The latest TSCA Inventory is now available here.

This biannual update to the public TSCA Inventory is part of EPA’s regular posting of non-confidential TSCA Inventory data. The next regular update of the Inventory is planned for winter 2022.

The Inventory contains 86,607 chemicals of which 41,953 are active in U.S commerce. Other updates to the TSCA Inventory include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA section 4 test orders and TSCA section 5 significant new use rules (SNURs).

In April 2021, EPA released a list of 390 chemicals expected to lose their confidential status and move to the public portion of the Inventory. EPA continues to work on finalizing the declassifications for these chemicals and plans to include them in the next public posting of the TSCA Inventory.

Maine (USA): Prohibition of Products Containing Perfluoroalkyl and Polyfluoroalkyl (PFAS) Substances, House Paper 1113, Legislative Document 1503 Enacted, 2021

This bill, now signed into law under 38 MRSA §1612, prohibits the sale, offer or distribution for sale of a product containing intentionally added PFAS.

Prohibition Effective January 1, 2023: carpets or rugs, and fabric treatments containing intentionally added PFAS.

Prohibition Effective January 1, 2030: any product containing intentionally added PFAS.

– Products containing PFAS identified by the Department as unavoidable use, and sale of used products, are exempted.

Effective January 1, 2023, a manufacturer of a product for sale in Maine containing intentionally added PFAS must submit a report that includes: brief description of the product; purposed use of PFAS in a product, including components, and other information.

The Department may prohibit the sale of products containing intentionally added PFAS as identified by category or use, prioritizing the most likely to cause contamination of the State’s land or water resources. The Department may waive all or part of the notification requirement under subsection 2 if the department determines that substantially equivalent information is publicly available.

China: Implementation of the “Stockholm Convention on Persistent Organic Pollutants” Prohibiting the Production and Use of Hexabromocyclododecane, Notice No. 237, 2021

On 4 June 2021, the China Ministry of Ecology and Environment, the China Ministry of Industry and Information Technology (MIIT), the China State Administration for Market Regulation (SAMR) and the Chinese Ministry of Housing and Urban-Rural Development jointly published a notice about the relevant management action on implementation of the “Stockholm Convention on Persistent Organic Pollutants” prohibiting the production and use of hexabromocyclododecane.

In accordance with this Notice, and with Announcement No. 84 of 2016, the production, use, import, and export of hexabromocyclododecane should be banned from 26 December 2021.

This Notice describes measures put in place to ensure that compliance goals are achieved as scheduled. These include:

  • Further investigation on companies producing or using hexabromocyclododecane: the production and use of hexabromocyclododecane in each region will be investigated and tracked in a register, to be dynamically and rigorously managed;
  • Relevant departments should clarify the responsibility of the enterprises, and ensure the production and use of hexabromocyclododecane will be completely stopped from 26 December 2021;
  • Strengthen the supervision and management of illegal production and sale of HBCD and products containing HBCD;
  • Strengthen the environmental supervision and management of the disposal of waste stocks of hexabromocyclododecane: the remaining hexabromocyclododecane stocks on 26 December 2021, must be disposed of as hazardous wastes in accordance with the “National Catalogue of Hazardous Waste (2021 Version)”.

The relevant actions taken by local authorities need to be reported to the China Ministry of Ecology and Environment before 31 March 2022, and a copy shall be submitted to the China Ministry of Industry and Information Technology (MIIT), the China State Administration for Market Regulation (SAMR) and the Chinese Ministry of Housing and Urban-Rural Development.

EU Environmental Policy to 2030: A Systemic Change

What are the goals of the new EU Environment Action Plan to 2030 and what has to be done to achieve them?

As Europe, along with the rest of the world, faces the economic and societal impact of climate change, ecosystem degradation and overconsumption of natural resources, MEPs will vote on the EU’s Environment Action Programme 2030, which aims to tackle some of the issues.

Find out about EU responses to climate change

Towards a climate-neutral EU

In November 2019, Parliament adopted a resolution declaring a climate emergency and urged the European Commission to ensure that future legislative and budgetary proposals are aligned with the objectives of the Paris Climate Agreement.

The first EU Environment Action Programme in 1973 aimed to reduce pollution, improve natural and urban environments and promote awareness of ecological problems. The 8th environmental action programme, which will be discussed by MEPs during July’s plenary session, will focus on accelerating the transition to climate neutrality, to clean and efficient energies and to a circular economy.

A sustainable economy is key

In its State of the Environment report, the European Environment Agency said that economic activities and lifestyle are Europe’s most important environmental challenges.

According to Parliament’s environment committee, the EU should shift towards a sustainable well-being economy with the Sustainable Development Goals as the foundation. A wellbeing economy is one where public interest determines economics and not the other way around.

The priorities in the action plan proposal include:

  • Environmental damage should be seen as a priority, rectified at source and damage paid for by the polluter
  • Mid-term evaluation by the Commission in March 2024
  • Data technologies should be used to support environment policy, ensuring transparency and public accessibility of the data
  • The phase out of all direct and indirect fossil fuel subsidies by 2025 and subsidies which fund environmentally harmful activities to be phased out by 2027.

Transparency and monitoring 

The new Environment Action Programme, which will support the European Green Deal, will include a new monitoring mechanism. The Commission is expected to come up with indicators to monitor and track progress by 31 December 2021.

California’s identification and ranking of substances for hazard assessment under Proposition 65 included PFOS and PFDA, PFHxS, PFNA, and PFUnDA and related substances

In March, the OEHHA (Office of Environmental Health Hazard Assessment) selected for hazard assessment several per- and polyfluoroalkyl substances (PFAS) for review and possible listing.  The chemicals are under review by two expert committees: the Carcinogen Identification Committee (CIC) and the DARTIC (Developmental and Reproductive Toxicant Identification Committee).  Under evaluation as carcinogenic and/or reproductive hazards are PFOS and its salts and transformation and degradation precursors; and PFDA and its salts, PFHxS and its salts, PFNA and its salts, and PFUnDA and its salts.

In a summary released this spring, OEHHA listed 22 substances reviewed and ranked by DARTIC from High Priority to No Priority for assessment.  OEHHA has discretion to determine which if any will be considered for listing under Prop 65:

Chemical Recommended Priority
Benzophenone 3 High priority
Bisphenol S (BPS) High priority
Diazinon High priority
Glyphosate and its salts High priority
Perfluorodecanoic acid (PFDA) High priority
Perfluorohexanesulfonic acid (PFHxS) High priority
Perfluorononanoic acid (PFNA) High priority
Imidacloprid Medium/High priority
Acetamiprid Medium priority
Butyl paraben Medium priority
Clothianidin Medium priority
Domoic acid Medium priority
Manganese Medium priority
Methyl paraben Medium priority
Perfluorodecanoic acid (PFUnDA) Medium priority
Titanium dioxide nanoparticles Medium priority
Zearalenone Medium priority
Thiamethoxam Medium priority/No priority
Vinpocetine Medium priority/No priority
Diethyl phthalate No priority
Isobutyl paraben No priority
Propyl paraben No priority